AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study

Phase 4

Completed

• Conditions: Coronary Occlusions
• Interventions: Device: everolimus-eluting stent

• Registration Number: NCT01012869
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis. Although everolimus-eluting stents (EES) \[(Xience, Abbott Vascular) or Promus (Boston Scientific)\] are very promising for the treatment of CTOs due to their low late loss and excellent deliverability, there are currently no published data on EES implantation in CTOs.

The specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of \> 50% of the minimum lumen diameter of the target stent) after implantation of the EES in CTO.

It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Status Verified: 2012-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age > 18 years old
2. Successful treatment of a native coronary artery CTO (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents
3. Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months
4. Agree to participate and provide informed consent

Exclusion Criteria

1. Planned non-cardiac surgery within the following 12 months
2. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
3. Coexisting conditions that limit life expectancy to less than 12 months
4. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
5. History of an allergic reaction or significant sensitivity to everolimus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
everolimus-eluting stent	everolimus-eluting stent	patients undergoing treatment of a coronary chronic total occlusion (at least 3-months old) using everolimus-eluting stents (Xience, Abbott Vascular) or Promus (Boston Scientific)

Primary Outcome Measures

Name	Time	Method
In-stent binary angiographic restenosis rate	8 months

Secondary Outcome Measures

Name	Time	Method
In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography	8 months
Percent stent strut coverage, as assessed by optical coherence tomography	8 months

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States